Kornimate/medical-research-clean huggingface dataset:
diabetes research on patient stratification

Conditions: Type2 Diabetes

Summary: the overarching goal of the imi direct (innovative medicines initiative diabetes research on patient stratification) consortium is the identification of biomarkers that aid therapeutic targeting in prediabetes (study 1) or early onset type 2 diabetes (study 2).

there are two multicentre prospective cohort studies within the glycaemic deterioration work package of imi direct (wp2). these two cohorts are designed to address the area of glycaemic deterioration by amassing data and biomaterials that will be used to discover novel biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes (study 1) and in those who have recently been diagnosed with the disease (study 2).

Eligibility criteria:
study 1 inclusion criteria * no treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs * fasting capillary blood glucose \<10 mmol/l at baseline * white european (self-report of parental ethnicity) * age ≥35 and \<75 years exclusion criteria * diagnosed diabetes of any type, hba1c ≥6.5% (48 mmol/mol) or fasting plasma glucose ≥7.0 mmol/l or 2 h plasma glucose \>11.0 mmol/l previously * for women, pregnancy, lactation or plans to conceive within the study period * use of a pacemaker * any other significant medical reason for exclusion as determined by the investigator study 2 inclusion criteria: * patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination * management by lifestyle with or without metformin therapy * all hba1c \<7.6% (\<60 mmol/mol) within previous 3 months * white european * age ≥35 and \<75 * estimated gfr \>50 ml/min' exclusion criteria: * type 1 diabetes * a previous hba1c \>9.0% (\>75 mmol/mol) * prior treatment with insulin or an oral hypoglycaemic agent other than metformin * bmi \ 50 kg/m2 * pregnancy, lactation or plans to conceive within the study period * any other significant medical reason for exclusion as determined by the investigator

Keywords: gene-environment interaction genome glycaemic control lifestyle microbiome prediabetes proteome type 2 diabetes
study to evaluate the clinical activity and safety of oral nx-13 in moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: phase 2 induction study with a long-term extension (lte) period in participants with moderate to severe ulcerative colitis (uc).

this is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory phase 2 induction study with a long-term extension (lte) period in participants with moderate to severe ulcerative colitis (uc).

Eligibility criteria:
inclusion criteria: * adult subjects aged 18 to 75 years (inclusive) * diagnosis of uc ≥ 90 days before screening confirmed by histologic evidence * active uc defined as a total mayo score (mms) of ≥ 5 (inclusive) at baseline * es ≥ 2 within 14 days prior to randomization * rbs ≥ 1. exclusion criteria: * severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for uc (e.g., colectomy) within the 12 weeks after randomization; * current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation * diagnosis of crohn's disease (cd) or indeterminate colitis, or the presence or history of a fistula consistent with cd * diagnosis of microscopic colitis, ischemic colitis, or radiation colitis * bacterial or parasitic pathogenic enteric infection;

Keywords: ulcerative colitis moderate severe
a study of rebastinib (dcc-2036) in combination with carboplatin in patients with advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumor

Summary: this is an open-label phase 1b/2 multicenter study of rebastinib (dcc-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (pk) in participants with advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. male or female patients ≥18 years of age at the time of informed consent. 2. part 1 (dose escalation). histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment. 3. part 2 (dose expansion) * previously treated, triple-negative breast cancer. * recurrent platinum-sensitive ovarian cancer. * histologically confirmed pleural or peritoneal malignant mesothelioma. 4. ecog performance status of ≤2. 5. able to provide an archival tumor tissue sample. 6. adequate organ function and bone marrow reserve. 7. if a female of childbearing potential, must have a negative pregnancy test prior to enrollment. 8. patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures. exclusion criteria: 1. received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose. 2. not recovered from prior-treatment toxicities to grade ≤1 or baseline. 3. peripheral neuropathy of any etiology \>grade 1. 4. concurrent malignancy. 5. known active cns metastases. 6. use of systemic corticosteroids. 7. known retinal neovascularization, macular edema or macular degeneration. 8. history or presence of clinically relevant cardiovascular abnormalities. 9. qtcf \>450 ms in males or \>470 ms in females. 10. left ventricular ejection fraction (lvef) \<50% at screening. 11. arterial thrombotic or embolic events. 12. symptomatic venous thrombotic event. 13. active infection ≥grade 3. 14. known hiv or hcv infection only if taking medications excluded per protocol, active hbv, or active hcv infection. 15. use of proton pump inhibitors. 16. if female, the patient is pregnant or lactating. 17. major surgery 4 weeks prior to the first dose of study drug. 18. malabsorption syndrome or other illness which could affect oral absorption. 19. known allergy or hypersensitivity to any component of rebastinib or any of its excipients. 20. any other clinically significant comorbidities.

Keywords: rebastinib breast cancer ovarian cancer mesothelioma
phase 2 study of darbepoetin alfa extended dosing

Conditions: Pre-Dialysis

Summary: multicenter, open label single arm study in which 140 subjects with cri who are currently receiving sc darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. the initial dose will be equivalent to the subject's total dose in the month preceding enrollment. doses may be titrated to maintain the hb concentration in the target range.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * cri with a creatinine clearance of greater than 15 but less than 40 ml/min * stable once every other week darbepoetin alfa sc for at least 6 weeks * hb values during screening / baseline of 10.0 - 12.0 g/dl * serum b12 and folate levels above the lower limit of normal and iron replete exclusion criteria: * receiving renal replacement therapy * uncontrolled hypertension * hyperparathyroidism * major surgery, active inflammatory disease, receiving antibiotics, hiv-positive * current malignancy * pregnant or breast-feeding
the effects of empagliflozin on renal outcomes in post severe acute kidney injury survivors

Conditions: Empagliflozin in Post AKI Stage 2-3

Summary: effects of empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by make365.


Eligibility criteria:
inclusion criteria: * post aki stage 2-3 * crcl \> 20 exclusion criteria: * pregnancy * post kidney transplant * previous use of sglt2 inhibitors * history of ketoacidosis

Keywords: empagliflozin aki
vitamin c and liraglutide effects on hypoglycemia-induced oxidative stress, inflammation and endothelial dysfunction in type 1 diabetes.

Conditions: Type 1 Diabetes Mellitus

Summary: to investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus. the vascular damage is evaluated at investigating the changes of endothelial function

to investigate the effect of antioxidants (vitamin c) on the vascular damage induced hypoglycemia in patients with type 1 diabetes. the vascular injury was evaluated in the same way as main objective. checking the existence of a peripheral response to the action of glp-1 due to oxidative stress.

Eligibility criteria:
inclusion criteria: * informed and signed consent obtained before any trial-related activity . ( trial-related activities are those procedures that were not performed during routine medical examination of the patient) . * diagnosis of type 1 diabetes. * patients who do not have autonomic dysfunction , defined by ( 1). * patients not showing episodes of hypoglycemia unawareness based on the methods of gold et al (2) . * patients without microvascular complications of diabetes. * patients without macrovascular complications of diabetes. * patients treated with multiple daily injections of insulin. * no smoking . * they should have a complete blood count, lipid profile, liver profile , renal profile and plasma electrolyte levels within normal values . * no subject must have a history of hypertension or taking medication for high blood pressure . * no subject should be taking medications known to affect the neuroendocrine responses to hypoglycemia or anti inflammatory exclusion criteria: * known or suspected hypersensitivity to study some related products. * fertile women, lactating or pregnant, intend to become pregnant or who are not using adequate contraception, or men who have sexually active and are not sterilized surgically, those whose partners are not using a method adequate contraception. * clinical diagnosis of type 2 diabetes.
clinical study of adipose derived mesenchymal stem cells for treatment of pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.mesenchymal stem cells (mscs)are a subset of adult stem cells residing in many tissues, including bone marrow(bm), adipose tissue, umbilical cord blood. recent experimental findings have shown the ability of mscs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues.it was found that mscs can significantly improve the pulmonary hemodynamics, lung tissue gross and decrease the pulmonary artery pressure, middle artery thickness and right cardiac hypertrophy by intravenous injection.


Eligibility criteria:
inclusion criteria: （1）40-75years （2）male or female （3）the patients that copd with moderate to severe pulmonary hypertension (pulmonary systolic pressure more than 40mmhg)in relatively stable period （4）to preliminary assess the patients'lifetime have more than 6 months （5）according to the researchers' judgment, they can abide by the research protocol or volunteer to participate in the clinical study, understand the study procedure and sign the informed consent in person. - exclusion criteria: 1. patients with acute myocardial infarction and cardiac surgery in the past 1 month 2. surgery may be required within 8 weeks 3. patients with prior pneumonectomy or having acute, chronic pulmonary embolism or other serious pulmonary diseases 4. having a history of malignant tumor 5. participated in other clinical investigators in the last 6 months 6. to allergic to penicillin, gentamicin, aminoglycoside, human serum albumin and dmem medium 7. a woman who is planning to pregnancy, gestation, or lactation 8. other reasons caused pulmonary hypertension and heart failure caused by other causes;severe liver and kidney failure;autoimmune diseases;patients with infectious diseases 9. according tothe researchers' judgments, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study 10. according to the researcher's judgment, this study is not suitable for other conditions -

Keywords: pulmonary hypertension（ph）mesenchymal stem cells(msc)
ventricular sling for heart failure with reduced ejection fraction

Conditions: Heart Failure; Cardiomyopathy, Dilated

Summary: the purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.

the sling is used to draw together the ventricular walls at the base of the papillary muscles. this technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients. the reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of mr when performed without mitral valve surgery in patients with symptomatic ventricular dilation.

Eligibility criteria:
inclusion criteria: patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for cabg surgery. suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below: * left ventricular end diastolic diameter is greater than or equal to 55mm. * ejection fraction ≥20% and ≤40% * fmr grade ≤ 2+ (≤ mild fmr) as defined by the guidelines of the american society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo). * end-systolic interpapillary muscle distance ≥ 20mm * cardiomyopathy of ischemic or non-ischemic origins. * able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf. exclusion criteria: * any evidence of structural (chordal or leaflet) mitral lesions. * planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization) * planned concomitant intra-operative maze procedure for symptomatic paroxysmal atrial fibrillation. * persistent atrial fibrillation * prior mitral valve repair * contraindication for cardiopulmonary bypass * clinical signs of cardiogenic shock * st segment elevation myocardial infarction within 14 days prior to inclusion in this study. * congenital heart disease (except pfo or asd) * chronic renal insufficiency defined by creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery * recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator * pregnancy
abt-450/ritonavir/abt-267 (abt-450/r/abt-267) and abt-333 in treatment-naïve and treatment-experienced, non-cirrhotic asian adults with subgenotype 1b chronic hepatitis c virus (hcv) infection

Conditions: Hepatitis C Virus (HCV)

Summary: this is a study to evaluate abt 450/r/abt-267 and abt-333 in treatment-naïve and treatment-experienced asian adults with subgenotype 1b chronic hcv without cirrhosis.


Eligibility criteria:
inclusion criteria: * chinese, south korean, and taiwanese descent with full chinese, south korean, and taiwanese parentage * chronic hepatitis c virus (hcv) infection prior to study enrollment. * screening laboratory result indicating hcv subtype 1b (gt1b) infection. * per local standard practice, documented absence of cirrhosis. * participant has never received antiviral treatment (including interferon \[ifn\]-based therapy \[alpha, beta or pegylated (peg)ifn\] with or without rbv) for hcv infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): non-responder or relapser * participant has plasma hcv rna level \> 10,000 iu/ml at screening. exclusion criteria: * hcv genotype performed during screening indicating unable to genotype or infection with any hcv genotype other than gt1b. * positive test result at screening for hepatitis b surface antigen (hbsag), or hepatitis b virus dna (hbv-dna) \> lower limit of quantification (lloq) if hbsag negative, or anti-human immunodeficiency virus antibody (hiv ab) positive. * any current or past clinical evidence of cirrhosis. * any primary cause of liver disease other than chronic hcv infection. * screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function. * use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inhibitors of cytochrome p450 3a (cyp2c8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

Keywords: hcv infection chronic hepatitis c virus hepatitis c virus (hcv) genotype 1b
laser therapy for patients with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Muscle Pain; Chewing Function

Summary: systemic lupus erythematosus (sle) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. the musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. the most common symptoms when muscle involvement in sle are muscle atrophy decreased muscle strength and myopathy. sle activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, sle patients are accepted to be at higher risk for temporomandibular joint disorders (tmd). low-level laser therapy(lllt) is frequently used in the treatment of tmd due to its pain relief and anti-inflammatory effect. thus, in this study, lllt has been used to evaluate this treatment modality on the chewing function and pain values of sle patients with myogenic tmd.


Eligibility criteria:
inclusion criteria: * having myogenic temporomandibular joint disorder, * following a stable medical regime, * showing minimum pain intensity of 50 mm on the visual analog scale. exclusion criteria: * having concurrent systemic diseases, * using antimalarial drugs, * wearing removable prosthesis, * history of facial trauma.
new treatment algorithm to reduce spherical aberration after lasik correction for myopia

Conditions: Myopia; Astigmatism

Summary: the purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available idesign treatments.

post-lasik induction of spherical aberration is currently among the most prominent challenges for refractive surgery. the presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). a modified treatment planning software (tps) "vss-rx1 opm software" has been developed that uses a modified algorithm (software that designs the lasik treatment profile) to limit the induction of postoperative spherical aberration. commercially available software used to calculate the lasik treatment profile was used in one eye (active comparator \[i.e., control\]) and vss-rx1 opm software was used in the fellow eye (experimental). subjects were masked to the use of either the commercially available or vss-rx1 opm software.

Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age at the time of preoperative exam * best spectacle corrected visual acuity (bscva) of 20/20 or better * demonstration of refractive stability * anticipated postoperative stromal bed thickness of at least 250 microns * willing and able to return for all study examinations exclusion criteria: * pregnant, breast-feeding, or intend to become pregnant over the course of the study * concurrent use of topical or systemic medications that may impair healing * history of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality * evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) * known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course
cardiovascular manifestation of inflamatory bowel disease patient ( tissue doppler echocardiography and cardiac mri )

Conditions: Cardiac MRI in IBD Patient

Summary: 1. evaluation of cardiovascular changes using doppler echocardiography and cardiac mri in ibd patients 2. to detect the frequency of myocardial injury in ibd patients 3. to detect the sensitivity and specificity of echocardiography for the detection of cardiac injury in comparison to cardiac mri in ibd patients

the burden of extra-intestinal disease is high in patients with ibd, some of whom respond to or are prevented by treating the bowel inflammation, whereas others require specific treatment because they are independent of the underlying bowel inflammation . cardiovascular diseases are the major causes of mortality and morbidity worldwide. they may arise for various reasons such as obesity, type 2 diabetes, genetic, environmental, dietary, and lifestyle factors. besides all these, there is much evidence suggesting that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis . a most common systemic inflammatory disease is inflammatory bowel disease (ibd), which is a collection of ulcerative colitis and crohn's disease, a chronic intestinal disease that may arise due to different factors, and is precipitated by environmental and genetic susceptibility tissue doppler imaging (tdi) is a useful echocardiographic technique to evaluate global and regional myocardial systolic as well as diastolic function. it can also be used to quantify right ventricular and left atrial function. to date, cardiac magnetic resonance imaging (cmri) is mostly used to detect significantly decreased efs and abnormalities in wall motion. contrast enhancement (ce) cmr is a more sensitive technique of cmri and can detect areas of myocardial damage in patients with acute myocarditis .

Eligibility criteria:
inclusion criteria: * ibd patients presented with disease flare, which is grouped by the 3 domains of disease severity: * measurable inflammatory burden (c-reactive protein, mucosal lesions, upper gastrointestinal involvement, and disease extent. * disease course (including structural damage, history/extension of intestinal resection, perianal disease, number of flares, and extraintestinal manifestations) exclusion criteria: * patients with poor echocardiographic window, previously diagnosed as ihd, complete heart block, mitral stenosis, prosthetic mitral valve, congenital heart disease with a left to right shunt, and ckd patients will be excluded from the study.